OEM News, Regulatory

European Regulators OK AI-Enabled Radiology Software

The tool automatically segments the prostate gland in MRI scans and independently identifies pathological changes.

By: Michael Barbella

Managing Editor

FUSE-AI GmbH’s AI software Prostate.Carcinoma.ai has received EU Medical Device Regulation (MDR) certification. 
 
The software tool helps radiologists by automatically segmenting the prostate gland in MRI scans and independently identifying pathological changes, promising a 30% time saving per patient, according to the company. The software’s integration into existing clinical software systems ensures user-friendliness and preserves radiologists’ familiarity with their work environment. Additionally, radiologists have tested the product for their colleagues in an evidence-based clinical trial.
 
“This AI software is a testament to the interdisciplinary collaboration among scientists, AI developers, and radiologists. Receiving certification is a pivotal step, transitioning preliminary agreements into binding contracts and fully leveraging the software’s capabilities in clinical settings. This milestone substantially lowers investment risks into our company,” FUSE-AI Founder/CEO Matthias Steffen said.
 
The global market for medical image analysis software is estimated to be worth $4.54 billion in value and grow 9.9% annually.
 
The company is now integrates the Prostate.Carcinoma.ai algorithm into its existing radiology software. Prostate.Carcinoma.ai is the spearhead for a suite of AI-powered diagnostic assistance software for various medical indications, positioning FUSE-AI for global clinical presence and making the software a valuable tool in medical diagnostics.
 
FUSE-AI is a Hamburg, Germany-based e-health company founded in 2017 that develops intelligent software solutions.

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